13268 Federal Register / Vol. 89, No. 36 / Thursday, February 22, 2024 / Rules and Regulations 

3See Bauer v. DeVos, 325 F. Supp.3d 74, 106–07 

(D.D.C. 2018); Sierra Club v. Jackson, 833 F. Supp. 

2d 11, 28 (D.D.C. 2012). 

4Because a notice of proposed rulemaking is not 

necessary for this delay of effective date, the 

Commission is not required to prepare a regulatory 

flexibility analysis under the Regulatory Flexibility 

Act. See 5 U.S.C. 603(a), 604(a). 

document in the Federal Register 

establishing a new effective date. 

II. Administrative Procedure Act 

Notice and comment is not required 

when an agency delays the effective 

date of a rule under section 705 of the 

APA because such a stay is not 

substantive rulemaking; it merely 

maintains the status quo to allow for 

judicial review.3

To the extent that a delay in the 

effective date may be deemed a rule, 

such action is also exempt from notice 

and comment as a rule of procedure 

under 5 U.S.C. 553(b)(A).4 Alternatively, 

the Commission finds, for good cause, 

for the reasons stated above, that notice 

and solicitation of public comment 

regarding the delay of the effective date 

for the CARS Rule are impracticable, 

unnecessary, or contrary to the public 

interest pursuant to 5 U.S.C. 553(b)(B). 

Balancing the equities here, the 

Commission has determined that it is in 

the interests of justice to stay the 

effective date of the Rule to allow for 

judicial review. 

By direction of the Commission. 

April J. Tabor, 

Secretary. 

[FR Doc. 2024–03559 Filed 2–21–24; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA-2024–N–0017] 

Advisory Committee; Digital Health 

Advisory Committee; Addition to List 

of Standing Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

amending the standing advisory 

committees regulations to add the 

establishment of the Digital Health 

Advisory Committee (the Committee) to 

the list of standing advisory committees. 

DATES: This rule is effective February 

22, 2024. 

FOR FURTHER INFORMATION CONTACT: 

James Swink, Office of Management, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5211, Silver Spring, MD 20993, 

301–796–6313, James.swink@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Committee was established on October 

11, 2023, and notice of establishment 

was published in the Federal Register 

on October 12, 2023 (88 FR 70679). 

The Committee will provide advice to 

the Commissioner, or designee, on 

complex scientific and technical issues 

related to digital health technologies 

(DHTs). This also may include advice 

on the regulation of DHTs and/or their 

use, including use of DHTs in clinical 

trials or postmarket studies subject to 

FDA regulation. Topics relating to 

DHTs, such as artificial intelligence/ 

machine learning, augmented reality, 

virtual reality, digital therapeutics, 

wearables, remote patient monitoring, 

and software, may be considered by the 

Committee. The Committee will advise 

the Commissioner on issues related to 

DHTs, including, for example, realworld data, real-world evidence, 

patient-generated health data, 

interoperability, personalized medicine/ 

genetics, decentralized clinical trials, 

use of DHTs in clinical trials for medical 

products, cybersecurity, DHT user 

experience, and Agency policies and 

regulations regarding these 

technologies. The Committee will 

provide relevant expertise and 

perspective to improve Agency 

understanding of the benefits, risks, and 

clinical outcomes associated with use of 

DHTs. The Committee will perform its 

duties by providing advice and 

recommendations on new approaches to 

develop and evaluate DHTs and to 

promote innovation of DHTs, as well as 

identifying risks, barriers, or unintended 

consequences that could result from 

proposed or established Agency policy 

or regulation for topics related to DHTs. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of digital 

health, such as artificial intelligence/ 

machine learning, augmented reality, 

virtual reality, digital therapeutics, 

wearables, remote patient monitoring, 

software development, user experience, 

real-world data, real-world evidence, 

patient-generated health data, 

interoperability, personalized medicine/ 

genetics, decentralized clinical trials, 

cybersecurity, and implementation in 

clinical practice of and patient 

experience with digital health, as well 

as other relevant areas. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Non-Federal members of 

this committee will serve either as 

special government employees or nonvoting representatives. Federal members 

will serve as regular government 

employees. The core of voting members 

may include one technically qualified 

member, selected by the Commissioner 

or designee, who serves as an 

individual, but who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. 

The Commissioner or designee shall 

also have the authority to select from a 

group of individuals nominated by 

industry to serve temporarily as nonvoting members who are identified with 

and represent industry interests. The 

number of temporary members selected 

for a particular meeting will depend on 

the meeting topic. 

The Committee name and function 

have been established with the 

establishment of the Committee charter. 

The change became effective October 

11, 2023. Therefore, the Agency is 

amending § 14.100 (21 CFR 14.100) to 

add the Committee name and function 

to its current list as set forth in the 

regulatory text of this document. 

Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the Agency 

finds good cause to dispense with notice 

and public comment procedures and to 

proceed to an immediate effective date 

on this rule. Notice and public comment 

and a delayed effective date are 

unnecessary and are not in the public 

interest as this final rule merely amends 

§ 14.100 to include the name of the 

committee and its function that will be 

added consistent with the committee 

charter. 

Therefore, the Agency is amending 

§ 14.100 as set forth in the regulatory 

text of this document. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for part 14 

continues to read as follows: 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 89, No. 36 / Thursday, February 22, 2024 / Rules and Regulations 13269 

Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C. 

1451–1461; 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264, 284m, 284m–1; 

Pub. L. 107–109, 115 Stat. 1419. 

■ 2. In § 14.100, add paragraph (d)(6) to 

read as follows: 

§ 14.100 List of standing advisory 

committees. 

* * * * * 

(d) * * * 

(6) Digital Health Advisory 

Committee. 

(i) Date established: October 11, 2023. 

(ii) Function: Advises the 

Commissioner of Food and Drugs or 

designee in discharging responsibilities 

as they relate to ensuring that digital 

health technologies (DHTs) intended for 

use as a stand-alone medical product, as 

part of a medical product, or as a 

companion, complement, or adjunct to 

a medical product are safe and effective 

for human use. 

* * * * * 

Dated: February 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03618 Filed 2–21–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 525 

Publication of Burma Sanctions 

Regulations Web General License 6 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Publication of web general 

licenses. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is publishing one 

general license (GL) issued pursuant to 

the Burma Sanctions Regulations: GL 6, 

which was previously made available 

on OFAC’s website. 

DATES: GL 6 was issued on January 31, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

OFAC: Assistant Director for Licensing, 

202–622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; or 

Assistant Director for Compliance, 202– 

622–2490. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Background 

On January 31, 2024, OFAC issued GL 

6 to authorize certain transactions 

otherwise prohibited by the Burma 

Sanctions Regulations, 31 CFR part 525. 

GL 6 was made available on OFAC’s 

website (https://ofac.treasury.gov) when 

it was issued. The reference to 31 CFR 

part 594 in paragraph (a) of the GL 

rather than 31 CFR part 525 was an error 

in the original GL, which is reproduced 

in this publication. The text of the GL 

is provided below. 

OFFICE OF FOREIGN ASSETS 

CONTROL 

Burma Sanctions Regulations 

31 CFR Part 525 

GENERAL LICENSE NO. 6 

Authorizing the Wind Down of 

Transactions Involving Shwe Byain 

Phyu Group of Companies 

(a) Except as provided in paragraph 

(b) of this general license, all 

transactions prohibited by the Burma 

Sanctions Regulations, 31 CFR part 594 

(BuSR), that are ordinarily incident and 

necessary to the wind down of any 

transaction involving Shwe Byain Phyu 

Group of Companies (SBPG) or any 

entity in which SBPG owns, directly or 

indirectly, a 50 percent or greater 

interest, are authorized through 12:01 

a.m. eastern standard time, March 1, 

2024, provided that any payment to a 

blocked person is made into a blocked 

account in accordance with the BuSR. 

(b) This general license does not 

authorize any transactions otherwise 

prohibited by the BuSR, including 

transactions involving any person 

blocked pursuant to the BuSR other 

than the blocked persons described in 

paragraph (a) of this general license, 

unless separately authorized. 

Bradley T. Smith, 

Director, Office of Foreign Assets Control. 

Dated: January 31, 2024. 

Bradley T. Smith, 

Director, Office of Foreign Assets Control. 

[FR Doc. 2024–03625 Filed 2–21–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 587 

Publication of Russian Harmful 

Foreign Activities Sanctions 

Regulations Web General License 87 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Publication of a web general 

license. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is publishing one 

general license (GL) issued pursuant to 

the Russian Harmful Foreign Activities 

Sanctions Regulations: GL 87, which 

was previously made available on 

OFAC’s website. 

DATES: GL 87 was issued on February 8, 

2024. See SUPPLEMENTARY INFORMATION

for additional relevant dates. 

FOR FURTHER INFORMATION CONTACT: 

OFAC: Assistant Director for Licensing, 

202–622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; or 

Assistant Director for Compliance, 202– 

622–2490. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Background 

On February 8, 2024, OFAC issued GL 

87 to authorize certain transactions 

otherwise prohibited by the Russian 

Harmful Foreign Activities Sanctions 

Regulations, 31 CFR part 587. GL 87 was 

made available on OFAC’s website 

(https://ofac.treasury.gov) when it was 

issued. The text of this GL is provided 

below. 

OFFICE OF FOREIGN ASSETS 

CONTROL 

Russian Harmful Foreign Activities 

Sanctions Regulations 

31 CFR Part 587 

GENERAL LICENSE NO. 87 

Authorizing Limited Safety and 

Environmental Transactions Involving 

Certain Persons or Vessels Blocked on 

February 8, 2024 

(a) Except as provided in paragraph 

(c) of this general license, all 

transactions prohibited by Executive 

Order (E.O.) 14024 that are ordinarily 

incident and necessary to one of the 

following activities involving the 

blocked persons described in paragraph 

(b) are authorized through 12:01 a.m. 

eastern daylight time, May 8, 2024, 

provided that any payment to a blocked 

person must be made into a blocked 

account in accordance with the Russian 

Harmful Foreign Activities Sanctions 

Regulations (RuHSR): 

(1) The safe docking and anchoring in 

port of any vessels in which any person 

or entity listed in paragraph (b) of this 


lotter on DSK11XQN23PROD with RULES1